Health Bill - Standing Committee E

[Mr. Eric Illsley in the Chair]

Health Bill

Clause 16 - Accountable officers and their responsibilities as to controlled drugs

Andrew Murrison: I beg to move amendment No. 10, in clause 16, page 14, line 7, leave out ‘or appoint’.
This is a simple amendment, like all the best amendments. It is to do with a tautology; I am quizzing the Minister on the difference between “nominate” and “appoint”. Words are used sparingly in legislation, and I suspect that there is a clear legalistic difference between those two, but I would be grateful if she could clarify it for me.
Why should the individual be appointed? In the spirit of trying to reduce the number of people appointed to management positions in health services, it would seem entirely appropriate to nominate a suitable person who is adequately trained to do what is required. To make a new appointment would be contrary to the spirit of what Conservative Members are trying to achieve—and, I hope, to the Minister’s general direction of travel. We are trying to reduce the number of people employed in management capacities.
It is with those two strands of thought in mind that I tabled the amendment. First, we ask the Minister to clarify why we need both “nominate” and “appoint” in the Bill; secondly, we want to determine whether her intention is that the accountable officer of each responsible body should be a new appointee or somebody who is given the task in addition to those that they have already.

Jane Kennedy: We do not like the amendment because it would remove the option of the organisation deciding how to meet the requirements. The regulations will specify the requisite seniority of the accountable officer; they will probably have to be at board level. Other likely requirements will be that they have relevant clinical knowledge and are remote from the day-to-day dispensing of controlled drugs.
It is just within the bounds of possibility that very small trusts may not have someone who is clinically qualified and senior enough, yet sufficiently removed from the day-to-day dispensing of controlled drugs, to fulfil those requirements. On those occasions, we expect that they may possibly have to consider  appointing somebody. In most cases, however, I expect that someone working for the trust will be nominated to fulfil that role.

Andrew Murrison: I am a little concerned about the Minister’s statement; if she is suggesting that small trusts may not have the expertise and therefore will have to appoint somebody officially, that would underscore my concern. The trick would surely be to find where that expertise exists in a neighbouring trust and to acquire those skills by buying them in. That would be better than appointing an individual to perform that function in a small trust where, presumably, the work load would be rather less.

Jane Kennedy: And, indeed, if we allow the trust flexibility, so that it has a range of options open to it, including that of bringing in someone at the necessary level with capacity, that would be the best position. The hon. Gentleman’s amendment would restrict that flexibility unnecessarily.
By and large, we expect that someone already working for the health care organisation will become the appointed officer, but there is facility under the Bill for two organisations to have a joint appointment. While meeting the requirements of our response to the Shipman inquiry, we want to allow as large a degree of flexibility as possible, so that health organisations can respond in an appropriate way locally. I appreciate that this is a probing amendment, and I hope that I have been able to reassure the hon. Gentleman so that he feels able to withdraw it.

Andrew Murrison: I am very grateful to the Minister for her assurances on those points. It is a probing amendment, and she has told me pretty much what I wanted to hear. In the spirit of Christmas, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Murrison: I beg to move amendment No. 12, in clause 16, page 14, line 13, after second ‘is’, insert ‘(a)’.

Eric Illsley: With this it will be convenient to discuss amendment No. 13, in clause 16, page 14, line 14, at end insert—
‘(b)should not routinely be involved in the prescription or handling of controlled drugs;
(c)be a senior member of staff; and
(d)be in receipt of appropriate training.’.

Andrew Murrison: These two amendments are linked. The purpose of amendment No. 12 is purely to allow amendment No. 13. The function of amendment No. 13 is to establish some parameters for accountable officers. They will be powerful individuals; they will be given a significant role in the controlling of controlled drugs, and we should set some margins within which they must act.
Accountable officers should be senior. That is covered later in the Bill; it is suggested that they should report to a trust board member. I suggest that they should be a senior trust board member—not a non-executive director, but someone with executive responsibilities. It is appropriate for us to make it clear at this juncture that we want a senior individual to be  given these functions. They should not be junior in the organisation, because these are important powers, and we all know what kinds of situation arise in organisations: there is the potential for a junior person—somebody without much experience or clout—to be influenced in a particular direction by more senior staff or parts of the organisation. In the context of the powers and responsibilities we are addressing, we should avoid situations in which somebody who is relatively inexperienced—or even young—could be subject to persuasion by senior individuals or by parts of the organisation that they are looking into. I am sure that the Minister will agree that these powers should be given to somebody who is clearly senior within the organisation. That is the purpose of proposed new paragraph (c).
The person will clearly have to
“be in receipt of appropriate training.”
We covered that issue when we discussed enforcement under part 1; we agreed that those who are tasked with enforcement need to be appropriately trained. As with part 1, it is likely that many of those who are given powers as accountable officers will be new to the game; this will be a new aspect of their work, and they will not previously have been familiar with the subject. Although some might have had dealings with controlled drugs in the course of their duties, others will not. Given the importance of this role, it is vital that they are given training. The Minister will say that that is covered later in the Bill, but, once again, my thesis is that this is so important that it needs to be stated at the beginning of part 3. There must be appropriate training.
It is also appropriate that the accountable officer should not be involved first-hand in the prescription or handling of controlled drugs. If the person were nominated, it means that the individual would be working within the body in some other capacity, such as a practitioner who could be dealing with prescription-only medicines and controlled drugs. Under those circumstances—although I hesitate to use the term because it is a little crude—we could have a “poacher turned gamekeeper situation” that might turn difficult if the individual had to look at his part of the system or his own practice. It could cause conflict that would be wholly undesirable.
Although it is desirable that individuals who are the accountable officers have an understanding of controlled drugs and have had some background with them in their professional lives, it is undesirable that they should be involved with them in a front-line way for the duration of their appointment under part 3 of the Bill. That is the crux of amendments Nos. 12 and 13. I hope that the Minister will give them a fair wind.

Jane Kennedy: There is not a lot in the amendments with which I disagree, except that they should not be accepted. The issue of who should be an accountable officer has been the subject of public consultation on the guidelines that relate to the new inspection and monitoring arrangements. It is likely that the regulations will specify the seniority of the accountable officer as being probably at board level. Other likely  requirements are that they should have relevant clinical knowledge and be remote from the day-to-day dispensing of controlled drugs.
I agree with the intention underpinning the amendments that we need to ensure that the accountable officer fulfils certain requirements. However, I believe strongly that requirements are best put in regulations or guidance. Occasionally, it may not be appropriate or possible for an organisation to have an accountable officer who meets all the relevant qualifications. For example, the amendment suggests that the individual officer
“should not routinely be involved in the prescription or handling of controlled drugs”.
We could hold a whole debate about the definition of “routinely”. To use a specific example, in some small ambulance trusts, all senior members of staff handle controlled drugs on occasions. Making it clear that the requirements of such an organisation should meet such provisions would genuinely be better dealt with under regulations or guidance rather than being enshrined in the Bill. I hope that the hon. Gentleman will accept that and withdraw the amendment.

Andrew Murrison: The Minister has given me some reassurance. We shall return to the matter later in our proceedings. Perhaps then will be the time for a more expansive discussion about whether the Bill is adequate in such important respects. I am glad that she shares my worry, as expressed by the two amendments. With that in mind, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Andrew Murrison: I beg to move amendment No. 14, in clause 16, page 15, line 46, leave out subsection (10).
The amendment was tabled for two reasons. First, I am not too sure what the subsection means and, by suggesting its deletion, I hope I shall receive clarification from the Minister. Secondly, if I had a little glimmer of light at the end of my tunnel of ignorance, it was that I perceived that subsection (10) allows the specifics of the clause to be nullified to an extent and replaced by a generality to which it refers. If that were the case, we would be unhappy for the reasons that we have outlined in previous sittings. We want more specifics in the Bill and a reduction in its capacity to allow the Secretary of State for Health at some future date to do pretty well what she likes under regulation. The amendment wants clarification from the Minister of the meaning of subsection (10) and, if it means what I think that it means, to clip the wings of the Secretary of State when making regulations in the future and taking to herself yet more powers under the Bill.

Jane Kennedy: The amendment would limit the issues on which regulations relating to the accountable officer could be made to the detailed issues mentioned in subsections (5) and (7), as the hon. Gentleman said. Those two subsections deal with several topics, such as the conditions that anyone nominated or appointed as the accountable officer should meet and the main issues on which regulations relating to the accountable  officer will be needed. They also deal with the requirements that the accountable officer should fulfil and the monitoring and inspection responsibilities that they should have.
As the accountable officer role develops and new organisational structures come into being, new issues may arise, which it might be helpful to clarify in regulations. We therefore wish to keep the broad regulation-making power in subsection (1), although I suspect that the hon. Gentleman will not like that answer—Oppositions generally do not. However, Governments generally use such powers, although sparingly, and I do not recall using them very often. I hope that he accepts that the power is justified in this case and that he will not press the amendment.

Andrew Murrison: The Minister is absolutely right: I do not like the answer very much. I am relieved, however, that her explanation accords with my own, so my understanding of the clause was correct, which is a good thing. Clearly, I am not happy that the provisions give the Secretary of State more powers. As the Minister rightly said, Oppositions are generally reluctant to give Ministers powers unless they are absolutely necessary. The powers before us seem to have an anticipatory function: the Minister is saying that although we cannot foresee the circumstances in which they will be necessary, they might be necessary in the future, and that is why we have subsection (10).
All that leads me to think that we should oppose the provisions but, looking around the Room, I am not sure that we would get very far. Nevertheless, I hope that I have made it clear that we are not particularly happy with them. With that in mind and with a heavy heart and with great reluctance, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Question proposed, That the clause stand part of the Bill.

George Young: I want to press the Minister briefly on subsection (5)(g). As well as making provision for an accountable officer, the clause creates
“offences punishable on summary conviction by a fine”.
If we are going to set up a new organisation with new responsibilities, I quite understand that we shall need to underpin it with some sanctions. However, if an offence is committed—the accountable officer discovers, say, that consistently inadequate records are kept about drugs—and it is sufficiently serious to be taken further, who will bring the case? Will it be the accountable officer, who will be appointed under clause 16, or the relevant authority, which will have appointed the accountable officer? Will they have to get hold of the police or the Crown Prosecution Service to prosecute? Who will take the provisions in subsection (5)(g) forward?

Jane Kennedy: The accountable officer will supervise the management of controlled drugs in the trust. There will be a requirement to share the data—that will be done on an anonymised basis so that patients’ details are not shared—with organisations such as the police. If practices of a criminal nature came to light, I anticipate that they would be dealt with by the appropriate authority. If it became clear as a result of monitoring the controlled drugs that there was, for example, a lack of training or a lack of understanding about protocols, one would expect that to be dealt with differently by the professional bodies responsible for the development of such protocols. I hope that that assures the right hon. Gentleman.

George Young: So the police will be the ones to prosecute, if they want to, under the provision in paragraph (g)?

Jane Kennedy: Yes, in most cases. I have nothing further to add, and I hope that the Committee will give the clause a fair wind.

Andrew Murrison: As I said before lunch, the clause is extremely important, as it contains the first part of the Government’s plans following their report, “Safer management of controlled drugs”, which was their response to Dame Janet Smith’s fourth Shipman inquiry report. It is appropriate that we reflect briefly on Dame Janet’s recommendations, because we must decide whether they have been adequately reflected in the legislation that the Government want the House to accept.
Dame Janet made four recommendations in four main areas. She recommended an integrated multi-professional inspectorate to manage controlled drugs and to replace the current rather amorphous system of regulation made under other legislation. That is manifestly not what is proposed in clause 16 and subsequent clauses in part 3. The Minister must explain why that is, given Dame Janet’s clear proposals.
I make no particular judgment about whether Dame Janet’s model or the Minister’s is the most appropriate, although there are benefits to both. However, it would be useful if the Minister could say to want extent she has considered Dame Janet’s first recommendation, and why she has sought to follow a different route that has at its heart the appointment of accountable officers at local level rather than an overarching inspectorate.
Several overarching health care bodies have been established in this country in recent years, and an inspectorate of the sort that I describe would have fitted into that structure reasonably well. Some of us may therefore be a little surprised that Ministers have not pursued that line. It is pretty fundamental, and it is important that the Minister explains why she has taken the route that she has taken and not embarked on the direction of travel that Dame Janet believed to be appropriate.
Dame Janet also believed that we needed to strengthen our audit trail of controlled drugs, which is absolutely right. I am hopeful that we will cover some of these matters in depth in our discussions on part 3.  Our consideration of them will be complex, but vital if we are to prevent the tragedies such as those caused by Harold Shipman’s actions. It is vital to have an adequate audit trail and a system that is as foolproof as possible to ensure that there are no more such tragedies. We must also accept, however, that what happened under Shipman was the result of criminal activity, and that it might happen again under another devious, cunning and intelligent individual. Our job in Committee is to minimise the chances of it happening again.
Dame Janet also covered the need for better information to be given to patients. That is important, but clause 16 and successive clauses are remarkable for the absence of that element. They contain a passing reference to it, but nothing gives me any great confidence that Ministers have adequately explored that recommendation, which was in one of only four main areas on which Dame Janet passed judgment.
The fourth area that Dame Janet considered was the restriction of GPs’ prescription rights over controlled drugs, and prohibiting GPs from prescribing such drugs to themselves, to their families and beyond normal clinical practice. I hope that the audit trail will allow the accountable officer to deal with that. Again, it is important to appoint persons of sufficient seniority. For instance, one could foresee a well known senior GP—perhaps someone whom the accountable officer had worked with or even for—putting some pressure on him and trying to persuade him that what he was doing was part of his normal clinical practice.
Some leeway will be needed, because not all practitioners are the same; we have different ways of treating the same condition. Nevertheless, it is important that adequate scrutiny should be given to an individual’s clinical practice. For example, it would be remarkable for a dermatologist prescribing in the normal manner to prescribe courses of treatment with large amounts of diamorphine, the drug illicitly obtained by Harold Shipman. It is important that we pay particular attention to the audit so as to ensure that an individual’s prescriptions are appropriate for his area of practice.
The fifth inquiry is about the complaints mechanism and safeguarding patients. In truth, the two are closely linked. Some of the recommendations in the fifth report deal with what we are discussing today.
We need to reflect on what has already happened. When considering the proposals for accountable officers, around which all the rest revolves, it is important to note what has been achieved so far. When we come to assess whether the Bill has had any impact, we will need to establish where our starting point was. Our starting point has nothing to do with the conviction of Dr. Harold Shipman. It is now.
At this juncture, I ought to declare my interest as a doctor and a subscriber to the General Medical Council. It is not that my membership makes me particularly well disposed towards the GMC; it costs me a considerable sum every year to be a member in order that I can regulate myself. However, it is important to note the work that the GMC has done. It is customary to be anti-establishment about the  organisation, but the poor old GMC has had a pretty rough ride in the media in recent years. None the less, it has worked terribly hard to improve its image and the image of the medical profession—but, more importantly, it is trying to ensure that acts such as those committed by Shipman do not happen again. When we come to pat ourselves on the back, saying that the Minister has done a terribly good job with clause 16 and the other provisions that relate to the control of controlled drugs, we need to understand what has already happened. The fact is that the GMC has reduced substantially the likelihood of a Dr. Harold Shipman happening again.
We ought to think in terms of revalidation and the fact that doctors will have to requalify every five years, or re-establish their credentials as practitioners. That is new, and for many, particularly occasional practitioners such as myself, it will be quite onerous. Nevertheless, I hope that we can weed out those in the profession who are what I might charitably call vulnerable so that we can protect patients.
We have seen a shift towards larger practices. Dr. Harold Shipman practised largely on his own. With particular exceptions, the general direction today is away from such small practices—and for good reason, because the ability to compare and contrast practices is limited if one is a sole practitioner. That is not to denigrate in any way the excellent and admirable work that single-handed practitioners do, often in isolated and remote areas, nor is it in any way to condone the Minister’s general direction of travel towards mega-practices, which I abhor. Nevertheless, very small practices, particularly single-handed practices, have their problems in areas such as this where there is self-regulation and partners must compare what is going on and in that way to improve safety. These matters are changing all the time. We have the Healthcare Commission with all its powers and, surely to goodness, that wonderful body, which is doing great work, will look at this area of practice and other important areas such as health care, acquired infections and associated infections, which clearly involve patient safety.
We have local systems of clinical governance, and this is an important point to get across in the context of accountable officers. Clinical governance was not spoken of in a meaningful way 10 years ago. If we used the term at all it was simply a throwaway line, but it now has a very specific meaning. I welcome the appointment of accountable officers because that will improve clinical governance and the level of oversight of practices, and thereby improve patient safety. It is part of a larger issue involving clinical governance to ensure that what we do is safe and reasonable and all the while driving up standards.
The point of mentioning that is to establish that while clause 16 and others will be helpful by and large—we will certainly not oppose it but hope to offer suggestions to the Minister—we already have a benchmark, which was established after Shipman. I hope that even if we took the do-nothing option, the chances of something awful like Shipman ever  happening again would be very much reduced because of the way in which the professions regulate themselves. I think our constituents, the patients of the NHS, should be pleased and relieved that things have changed substantially since Shipman. Let us hope so.
Accountable officers will be given considerable powers, so we must be jealous of those powers, as we have been with Ministers. We have covered both of those matters during our discussion.
I should be grateful if the Minister could clarify an area of confusion. There seems to be a conflict between subsection (2) and subsection (5)(e), which refer to who can be called an accountable officer. One seems to establish that the person in question should be called an accountable officer, which is a change because they were to be called proper officers, which sounds rather Victorian. I think I prefer “accountable officer”. However, subsection (5)(e) is a bit Alice in Wonderland, and allows the person to be called whatever they want to be called or whatever their responsible body wants them to be called. I am a little confused, but I am sure that that is because of my lack of understanding rather than any fault in the drafting of the Bill. Some clarification for simple souls like me would be helpful.
Subsection (5)(g) has been questioned by my right hon. Friend the Member for North-West Hampshire (Sir George Young) and I will leave it at that. However, I would like to refer to the safe disposal of controlled drugs because that has not been given as a specific function of the accountable officer. That strikes me as rather strange because controlled drugs do not just go from prescription pad to patient. They hang around. There is a supply chain before their use; after their use, when they have ceased to be useful or wanted, they still exist and need to be disposed of. There is no comment about the destiny of those medicines and how they will be handled. Shipman hoovered up those drugs—that was part of what he was about. He removed diamorphine from the homes of those who had died and stored it up. That lay at the heart of that terrible set of tragedies, in which more than 200 people ended up losing their lives. It seems strange that we should not have given any thought to what might happen to redundant controlled drugs—how they are to be safely disposed of and the role that the accountable officer might have in that.
Does the responsibility of the accountable officer or the body for which he works end when the prescription is made or discharged? Perhaps it does, although that does not seem helpful, particularly in the context of what led to Dame Janet’s report. It would be useful if the Minister said how we might address the specific issue of what to do with the redundant controlled drugs that are left after a person has ceased to need them.
We have not heard anything about the security of the supply chain in the context of controlled drugs. We do not know anything about controlled veterinary drugs. I am not an expert, but I rather suspect that the diamorphine used for veterinary purposes is similar to  that used for human purposes. If that is the case, one can see the potential for abuse. Clearly, the problem in the Harold Shipman case lay with his having personal access to the drug and a population on whom he could use it, apparently legitimately. That is less of an issue for veterinary surgeons, although, having said that, I suspect that I shall be roundly condemned by the animal welfare lobby. If we have that repository of controlled drugs in the veterinary profession, it is important that we make some allowance for it. If we are going to regulate controlled drugs in this way, I suggest that we need to reflect that in the Bill. However, it is not reflected there; there is no reference to accountable officers in the context of the veterinary profession.
There is a vague mention of training, to which I have referred already, in subsection (6)(c). My experience of health care bodies is that when resources are tight, training cops it first; that is my worry. The emphasis on training in my amendments is in part driven by the imperative to make sure that it is at the heart of what is going on in respect of clause 16 and its sister clauses. We must make it absolutely clear that training is not a bolt-on, added extra—not something that we will do if we can afford it—but something that, within the fabric of the clause and certainly in the context of accountable officers, is absolutely essential before we consider nominating or appointing anybody to that important position.
We have not considered new prescribers. The Government would like to bring on line new prescribers, particularly members of the nursing profession, such as those who work in palliative care. Quite rightly, the Government are attempting to extend the sorts of things that nurses can do autonomously. That is fine; we support them on that. However, the Minister needs to accept that as that is done, the envelope within which abuses may happen is widened. That is axiomatic. I should be interested to know what assessment the Minister has made of the increased risk that that otherwise desirable change will introduce.
We have not had any real mention of where the national programme for IT in the NHS, or NHS Connecting for Health, will fit in the context of accountable officers. I always get slightly nervous when a Government change the title of an organisation. That is what the Government have done in the case of NPfIT, which is now called NHS Connecting for Health, so it is hardly surprising when we open our newspapers and see that the whole thing looks like it is going for a ball of chalk. Nevertheless, it is important that the Minister says what part she expects NPfIT, or NHS Connecting for Health, or whatever we want to call it, to play in the audit trail and where accountable officers will be pegged within that. It is important that we use NPfIT to audit what is going on in the context of controlled drugs. Accountable officers will have to be well briefed on the use of IT and NPfIT.
It would be nice to know if the Minister accepts the importance of NPfIT and NHS Connecting for Health in the audit of controlled drugs. What happens if Mr.  Granger’s dismay is well placed and the whole thing comes to a sticky end? Where does that leave this crucial function? There are 101 other important functions that no doubt are relying on the success of NPfIT, but we are talking about one function that might rely heavily on it. What happens if we do not have that strand of the audit trail as a result of the collapse of NPfIT and NHS Connecting for Health?
I must press the Minister and ask why she has decided on this model for the control of controlled drugs, rather than Dame Janet Smith’s recommendation for an overarching structure. That is a crucial point. I make no judgment on which I think would be better—I am not necessarily in as good a position to judge as the Minister is—but no doubt she will have considered both options, which are fundamentally different. It would be interesting if the Minister could give us some idea of the thought processes that have gone into determining that accountable officers are the preferable model, rather than the overarching inspectorate that Dame Janet wanted.
Dame Janet’s model might have put in place a more manageable structure for connecting various responsible bodies. We will discuss, in the debate on clause 17, co-operation between health bodies and other organisations. I can see real difficulties under this system, with accountable officers of health care bodies having to decide whether and how they should co-operate with their neighbour. All sorts of issues to do with confidentiality arise. There will be deliberation about whether it is reasonable in a particular circumstance to divulge information. We are dealing with what are often sensitive cases: not people going into hospital to have their hernia repaired, or their in-growing toenail sorted out, but people who are often vulnerable and certainly would not want their medical condition divulged to anybody outside their immediate medical advisers. We are talking about highly sensitive information and, unless we get the confidentiality issue right, I can see people being put off seeking medical care and, perhaps, putting off going to methadone clinics because they are concerned that the information will be shared with their GP, for example. One advantage of Dame Janet’s model would be that the overarching structure might pull together all the different NHS bodies and individual bodies would not be faced with the dilemma of whether to share precious information with somebody else in an undefined way and thereby breach medical confidentiality.
I am sure that the Minister will have sought the advice of ethicists about the matter before going down this pathway, but it is a hornet’s nest. Because there is uncertainty, I suspect that bodies will be reluctant to share information even when it is appropriate that they should do so. One chief advantage of the multi-professional, over-arching jobbie suggested by Dame Janet is that it would, to a large extent, get round the issue of co-operation and sharing information, which could be something of a showstopper in certain circumstances. I shall end with that, if I may. The Minister has a good idea of the issues that I am  concerned about, but I ask her specifically to address why she has decided to take up the accountable officer model outlined in clause 16 and not the overarching inter-professional model recommended by Dame Janet.

Jane Kennedy: The hon. Gentleman asked many detailed questions. If I miss some of them, I may need to write to him and to the Committee. I shall begin with a couple of quick responses. On the hon. Gentleman’s fears about extensions to independent prescribing—that is, the role of nurse prescribers and, to a degree, of pharmacy technicians—controlled drugs would not be prescribed. Even in the case of palliative care, a nurse prescriber would prescribe such drugs only if directed by the clinical management plan agreed by a doctor. With regard to vets, there are observers from the Department for Environment, Food and Rural Affairs and the field of veterinary science on the controlled drugs advisory group, and we are working with them to develop policy in that area.
The hon. Gentleman has caused us to pause for a moment to consider the serious circumstances under which we are doing this work. As he said, the role of the accountable officer is part of a package of provisions intended to strengthen the governance and accountability arrangements for the safe management of controlled drugs in health care. The clause provides the legislative framework for the programme of action in the Government’s response to the fourth report of the Shipman inquiry, which I mentioned earlier.
Controlled drugs are medicines that are used to treat a variety of clinical conditions, such as severe chronic pain in palliative care. They are subject to special legislative controls because of the potential for abuse. As the hon. Gentleman correctly pointed out, that potential was illustrated by the Harold Shipman case, which led us to introduce these additional measures.
A key finding of the Shipman inquiry was that a variety of people had concerns about Dr. Shipman’s practice, but no single person had ever drawn together those concerns or the information held by individuals. The accountable officer will be responsible for all aspects of the safe and effective use and management of controlled drugs. The accountable officer will have information on the requisitioning, storage and destruction of controlled drugs in their organisation and information on the quality and quantity of prescribing and dispensing such drugs. That list may have answered some of the points that the hon. Gentleman raised.
The disposal of controlled drugs is specified in clause 23, which we have not yet reached. It defines the accountable officer’s responsibility to include disposal. The witnessing of destruction is covered in regulations to the Misuse of Drugs Act 1971. Some of the proposed changes to those regulations will provide accountable officers with a great deal of information about the prescribing habits of professionals in private and NHS practices. The data will be collated nationally and any discrepancies will be highlighted to  the accountable officer for follow-up at local level. I shall come to the issue that the hon. Gentleman raised about Dame Janet’s main recommendations.
Many of the measures required to enhance the audit trail will be covered by the Misuse of Drugs Act 1971, which is managed by the Home Office. I reassure the hon. Gentleman that officials from the Department of Health are working closely with the Home Office to put in place the measures that are necessary. It is our intention that all private prescriptions will be collected and analysed, all prescriptions for controlled drugs will require prescriber identification and all orders from manufacturers and wholesalers will be collated and analysed.
We are discussing restrictions to the prescribing of controlled drugs with the GMC, the General Dental Council, the Royal Pharmaceutical Society and the Nursing and Midwifery Council. We are currently working on that issue and, in some cases, those organisations are consulting their members on restrictions on prescribing. They are considering whether, for example, a practitioner should be able to prescribe controlled drugs for themselves or for their family. They have all been key stakeholders in developing the approach we adopted and I am grateful for the co-operation we have received from the professions in doing that.
In NHS primary care, the accountable officer of the primary care trust will be responsible for all its independent contractors, such as GPs, dentists and out-of-hours services. All NHS secondary care providers will be required to appoint an accountable officer. We accept the need for better oversight of the use of controlled drugs in the NHS. No one studying the Shipman case who then saw the outcomes of Dame Janet’s inquiry could argue with that. However, I have been persuaded that it is better done at local level as an integral part of the local clinical governance machinery.
The Healthcare Commission will give additional assurance that local arrangements are fit for purpose. The hon. Gentleman will be pleased to hear that we will make regulations to provide detail on which organisations must appoint an accountable officer and the criteria for that appointment. We have probably already covered that subject. The regulations will set out the responsibilities of the officer in relation to the management of controlled drugs including storage, carriage and safe custody, prescribing, administration, recovery and disposal of these drugs and the requirement to follow best practice. The regulations also allow for the creation of offences punishable by a fine, as we discussed briefly, and for other procedures for enforcing the provisions.
Although we cannot guarantee that the provisions would prevent another Harold Shipman, we are confident that poor practice would be detected much earlier if such measures were in place. That is why I am happy to commend the clause to the Committee.

Question put and agreed to.

Clause 16 ordered to stand part of the Bill.

Clause 17 - Co-operation between health bodies and other organisations

Andrew Murrison: I beg to move amendment No. 15, in page 16, line 47, at end insert—
‘(f)for measures to protect the confidentiality of patient records.’.

Eric Illsley: With this it will be convenient to discuss amendment No. 16, in clause 20, page 19, line 14, at end insert—
‘(e)confidentiality in the transfer of data that is attributable to individual patients between cooperating bodies.’.

Andrew Murrison: I was so taken with the Minister’s speech that I felt I ought to reflect on it and I could not find my place, but I have now.
We are largely content with the clause, but it deals with issues of confidentiality that trouble us a little. In my rather discursive remarks on clause 16, I said what I needed to say but I shall reiterate it in the context of clause 17. We need to be clear about the transfer of patient-identifiable material between various health bodies. That worries me considerably. I cite the example of a methadone clinic, where we are dealing with people who are quite vulnerable. We are not only dealing with the generality of medical practice, which is important in itself, but on top of that we are talking about people who have a range of conditions that are sensitive in many respects.
Controlled drugs can be used for a variety of things. They can be used for palliative care, but they can also be related to drug abuse and other sensitive areas of practice. Therefore, it is particularly important that we pay close attention to issues of medical confidentiality. We need to be clear that in transferring material from one body to another for the purposes of the clause, we are doing so in a way that is highly sensitive and preserves, as far as possible, the confidentiality of those individuals.
During this brief debate, I want to press the Minister on that matter and seek her assurance that she recognises the extent of the potential abuse that could take place and the possibility that people will be dissuaded from seeking medical advice for particular conditions if they are not absolutely confident that the organisation that they are seeking attention from will deal carefully and sensitively with information given to it in confidence. The way in which the provisions are drafted means that there is the potential for the whole thing to look far more diffuse to somebody who is seeking help in that way. That is my chief concern. We have talked about how Dame Janet’s initial recommendation might be of assistance in that respect, but clearly the Minister has chosen a different pathway. I hope that she can give me some assurances about the use of the information, particularly in respect of confidentiality.

Jane Kennedy: We do not feel that the amendments are necessary. I hope to reassure the hon. Gentleman that the necessary safeguards already exist. We already plan to provide advice to organisations to ensure that patient confidentiality is upheld. We have already  issued for consultation draft guidance on strengthened governance arrangements that makes it clear that organisations should follow existing NHS guidance on confidentiality and protect patient confidentiality. As part of that, the guidance makes it clear that patient information should normally be used only in an anonymised form. Where it is needed in an identifiable form, patient consent should be sought. The only exceptions to that would be where the organisation judges that there is a serious risk to health and safety that outweighs the need to maintain confidentiality. Guidance on confidentiality can already be issued under clause 20(1)(b), which we have not reached yet. That provision allows for guidance to be issued on the discharge of the accountable officer’s responsibilities.
I appreciate the spirit in which the hon. Gentleman has moved his amendment. He is right to reinforce the need to protect patient confidentiality. We believe that the clause does that and that the protocols and procedures are already in place to ensure that. However, I take his point. I hope that he will withdraw his amendment and accept the reassurances that I have offered.

Andrew Murrison: The Minister has sort of given me some reassurance. Obviously, she understands that this is a difficult area. I suppose that there is no obvious way forward. At the end of the day, if we are going to safeguards patients, clearly there will have to be some sort of transfer of information. The purpose of amendments Nos. 15 and 16, which apply to clauses 17 and 20 respectively, but which are closely related, was to make the Minister aware of our concerns about confidentiality. We have expressed those concerns elsewhere in connection with NHS Connecting for Health and NPfIT and no doubt we will return to the matter at greater length at some point in the future.
Some people might be discouraged from seeking treatment, which is a pity. However, at the end of the day, I guess that a judgment has to be made. I accept the Minister’s assurances and recognise that if we are to enhance the safety of patients, we will have to allow the transfer of information. I hope that it will not be patient-specific unless absolutely necessary and that it will be generic wherever possible. With that in mind, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.
Clause 17 ordered to stand part of the Bill.

Clause 18 - Controlled drugs: power to enter and inspect

Question proposed, That the clause stand part of the Bill.

George Young: The Committee should pause for 90 seconds—the length of time for which I propose to speak—before it confers on somebody other than a police officer the right to enter a citizen’s home against their wishes, which is what the clause does. From the definition of “any relevant premises” in subsection (7)  it seems that such premises could include the home of a pharmacist or GP. The powers to enter and inspect will not be confined to a police officer; they will be given to an authorised person who is defined in the clause.
If one considers subsection (2), which puts parameters around those powers, all one needs to do to exercise those powers is to turn up at a reasonable hour and produce the written authority of the person exercising them. The constraints seem rather flimsy on what could be a draconian power, particularly if one considers subsection (3)(b), when the person who has the power can take away relevant records kept on the premises. The least I should expect under subsection (2) is reasonable grounds for suspecting that an offence might have been committed, or, under the clause, guidelines about when the Government envisage the appropriate exercise of those powers. There is very little about that.
This is a potentially draconian power. It will be given to an authorised person, as defined in subsection (4), who can turn up any time before 9 o’clock at the home of a GP or a pharmacist and, with a letter, which is the written authority of the person exercising the power, demand to come in. We should pause for 90 seconds and press the Minister about exactly how those powers will be used.
The House has been sensitive about giving tax and VAT inspectors and Revenue and Customs employees the powers to enter peoples’ homes against their wishes. However, clause 18 extends that privilege with, as far as I can see, very little explanation about when the powers might be used.

Jane Kennedy: I have thought long and hard about the matter, and I share some of the right hon. Gentleman’s concerns that we should not take those powers lightly, and nor have we. Physical inspections, the power to enter the premises and to inspect, and the general powers in the clause are only one aspect of the new monitoring and inspection arrangements. Persons exercising those powers would not be able to enter the home of a GP or a pharmacist unless that home was used for the provision of health care or for the supply or administration of a controlled drug. That is the proviso.
When an inspector turns up to carry out a routine inspection, there will be no problem and the inspection will be complied with. A number of people, including in the case of pharmacists, the Royal Pharmaceutical Society, can do that. We anticipate that there may be occasions when objections will be made, but it is necessary to allow the inspectors the right to insist on being granted entry.
The intention is that routine inspections should normally be carried out by the accountable officers appointed under the clause that we have just debated. Inspections will be carried out also by regulated bodies that already have powers of entry. As the right hon. Gentleman rightly said, the powers may be used only at reasonable hours and with the production of written authority. The regulated bodies are not explicitly mentioned in the clause, as many already have powers  of entry to the relevant organisations. The Royal Pharmaceutical Society has the power to enter community pharmacies and request records.
I appreciate the concerns that the right hon. Gentleman has raised. The provision is not as draconian as he fears it may be; it will be used only on rare occasions and probably when there are already concerns about the premises to be inspected. I hope that he will reflect on my comments as I shall reflect on his.
We have not taken the powers lightly; we have thought about them carefully. In the context of the other package of measures that we are putting forward, the provision is an important part of the Bill.

Question put and agreed to.

Clause 18 ordered to stand part of the Bill.

Clause 19 - Offences in connection with power to enter and inspect

Question proposed, That the clause stand part of the Bill.

Andrew Murrison: There is very little with which we could take issue in the clause, as it is reasonably technical. However, I seek the Minister’s clarification. As I understand it, the clause would give penalties similar to those outlined in section 23 of the Misuse of Drugs Act 1971 in respect of a failure to allow access to the relevant person to commercial premises that have to do with controlled drugs. If the Minister were able to confirm that the penalties and the offences that are set out in the clause are similar to, and comparable with, section 23 of the 1971 Act, we would be content.

Jane Kennedy: I can give the hon. Gentleman that assurance. Those things are comparable. I hope that, in that brief way, I have been able to reassure him.

Question put and agreed to.
Clause 19 ordered to stand part of the Bill.
Clauses 20 to 23 ordered to stand part of the Bill.

Clause 24 - Requirements about supervision

Jane Kennedy: I beg to move amendment No. 90, in clause 24, page 21, leave out lines 10 to 14 and insert—
‘(7B)Conditions prescribed under subsection (7A) may relate to supervision in the case where the pharmacist is not at the place where the thing is being done, and in that case the thing is not to be so considered if no such conditions are prescribed.
(7C)In any case, compliance with any applicable conditions is sufficient for the thing to be so considered.” ’.

Eric Illsley: With this it will be convenient to discuss Government amendment No. 91.

Jane Kennedy: My habit in Committee is usually to move relatively quickly in order to make progress and to answer briefly at the end of a debate any concerns raised.
The clause seeks to make clear our intention to set out in regulations the requirements as to the conditions that must be complied with before a pharmacist may discharge his duty to supervise from another location, which is what we are introducing as part of the clause. As originally drafted, the measure provided simply that regulations could be made to specify what would constitute adequate supervision. If no regulations were made, the measure as originally drafted did not clarify whether or not the use of remote technology was otherwise acceptable. The provision is fairly straightforward, so I will sit down and see whether there is further debate on it.

Andrew Murrison: We have some concerns about the clause, which I hope that you will allow us to express in a clause stand part debate, Mr. Illsley. We seek clarification of the Minister’s expectations of pharmacists in respect of telemedicine and remote supervision of the sort that she mentioned. It is important that she understands the limitations of those media, and it is not clear from what she briefly said that she does. I would be grateful for further clarification about exactly what she is getting at by tabling the amendments.

Jane Kennedy: The amendment will clarify the pharmacist’s obligation and will make provision for the appropriate use of new technologies that enable pharmacists to supervise dispensing activity safely when away from pharmacy premises. The hon. Gentleman is right that we must consider what those technologies are. We intend to set out in regulations where the pharmacist is required to be personally involved in the preparation, sale and supply of medicines, or the supervision of those activities, and the conditions for use of new technologies.
For example, the conditions might include the use of technologies such as robotics or a video link, which can help the pharmacist meet their supervision obligations from another location. That is what we mean by remote supervision. With the aid of appropriate technologies, the pharmacist may continue to meet his or her responsibilities, through the ability to remain in contact, to provide professional advice to staff and patients.
In most circumstances, use of a telephone alone would be insufficient to meet the pharmacist’s supervision requirements. It would not allow the pharmacist to check the prescription being dispensed, and he would be reliant on information from pharmacy staff. Effectively, we are tightening the provisions.
However, there are technologies that allow the pharmacist to see a prescription electronically. Also, video links can support face-to-face contact with both staff and patients. We want new technologies to be used in a way that maintains patient safety. We intend to consult key stakeholders on the regulations, including conditions that could support remote  supervision through the use of new technologies. That way, the regulations will reflect the rapid pace of change in this area. I hope that that brief comment reassures the hon. Gentleman. I appreciate the spirit in which he raised his concerns.

Amendment agreed to.

Amendment made: No. 91, in clause 24, page 21, leave out lines 23 to 27 and insert—
‘(3)Conditions prescribed under subsection (2) may relate to supervision in the case where the pharmacist is not on the premises, and in that case the transaction is not to be so considered if no such conditions are prescribed.
(4)In any case, compliance with any applicable conditions is sufficient for the transaction to be so considered.’.—[Jane Kennedy.]

Question proposed, That the clause, as amended, stand part of the Bill.

Steve Webb: I am grateful for the opportunity for a brief stand part debate, because we are now on a new chapter of the Bill. It would be helpful if the Government could put on record a bit more of their thinking, because the clause gives them power to make various regulations. The pharmacists of Britain want to know a bit more about what is intended, so that they can plan ahead. I hope that the Minister will take our questioning in that spirit. We just want to understand a bit more about what is planned.
It is my understanding of the clause and this chapter of the Bill that the Medicines Act 1968 contained the concept of personal control by a pharmacist, to the extent that if the pharmacist pops over the road to a shop, or something like that, certain things cannot be sold. We are moving from that situation to one in which the pharmacist has to ensure that things are done under the supervision of a “responsible” pharmacist, not necessarily one on the premises. We have just heard the beginnings of a discussion about whether that would mean having a pharmacist on the other end of a video link, or that the pharmacist had put in place some other alternative arrangement.
I admit that I have an open mind on the subject. Certainly, it seems a reasonable assumption that there may be people working in pharmacies other than fully qualified pharmacists who have skills that have not so far been tapped. I am all in favour of using the talents of those who have already had some training and could do some things. The problem is the all-or-nothing nature of the provision. In one way, I am more relaxed about a pharmacist being on the other end of a video link in another pharmacy than about a pharmacist simply being off the premises and therefore uncontactable in some sense.
The Minister may say that the Government are asking pharmacists to put in place structures—that is, to train people, to have procedures and protocols, and to have feedback at the end of the day on what was prescribed and to whom, and so on. It seems an all-or-nothing issue, because currently we say that a person cannot be sold medication that is not on the general sale list unless the pharmacist is physically there, but clause 24 and succeeding clauses take away that  requirement. I guess the question is, if it has been necessary for the last 37 years to have a pharmacist present, what has changed? Have we been over-regulating for 37 years?
Jane Kennedyindicated assent.

Steve Webb: The Minister nods, which is interesting. So, have we been over-regulating, or are we reacting to a shortage by lowering standards? If we are saying, “Actually, we never really needed the pharmacists to be there, and 37 years on, we have just realised it,” then that is a strange argument. The regulatory impact assessment says that the provisions in the 1968 Act were unclear in that respect, which is interesting. We have got by with them for 37 years, and only now do we seem to need to clarify them. That is surprising.
What sorts of requirements are we talking about? The Royal Pharmaceutical Society has suggested that the regulations should include provisions for the responsible pharmacist to be contactable when absent and in a position to return without undue delay. It would be helpful if the Minister could clarify whether that is the sort of thing that the Government have in mind.
For example, if simply being on the other end of a video link is good enough, why should not a qualified pharmacist be in charge of not one or two but 10 or 15 pharmacies? He or she could sit in front of their video link all day, dispensing—if that is the right word—wisdom. In respect of clause 24 and later clauses, once we have agreed that someone does not physically have to be present, there is no obvious reason why the number should be restricted to two or three. There is the potential to go a long way from where we are now. The Minister may say, “No, we don’t mean that, we just mean they can pop out to meetings with local GPs for half an hour,” but either pharmacists need to be there or they do not. If they do not need to be there, but just to be accessible, the powers given by the clause could be far-reaching.
However, unless the Government intend to specify in regulations that pharmacists can be responsible for, say, only two premises simultaneously, or if no limit is specified in regulations, the change could be far more radical than we have been led to believe.
I have misgivings about the view that we have been wrong for 37 years and now we need to change, that the regulations so far have been unduly restrictive and that it is safe to relax the restrictions. The Committee must therefore know far more about what the Government plan to put in the regulations that the clause gives them the power to introduce. I have a number of reservations and anxieties and I look forward to hearing what the Minister has to say.

Andrew Murrison: What has changed in the past 37 years are the expectations we put on pharmacists. The hon. Member for Northavon (Steve Webb) made an interesting point: he asked why limits were being imposed and why there could not simply be a central pharmacists’ bureau—“Pharmacy Direct” or something like that—from which someone sitting  centrally could dispense advice with the aid of telemedicine and the telephone. A case could be made for that being okay in terms of patient safety. If someone can read the prescription on the computer screen and electronically accept that it is appropriate, it should be all right. Indeed, because it provides an audit trail, theoretically such a system might even be better than someone just giving the nod and the wink to a prescription in a pharmacist’s shop.
What seems to have changed in the past few years is what we expect of pharmacists. What Ministers expect, and what Conservative Members would support, is the extended role of the pharmacists, which means face-to-face contact. I do not know the intention of the limits that the Minister wishes to set on the absence of pharmacists from their premises, or what drives it. It is said to be safety, but I suspect, and hope, that it might be more than that. I hope that it is a desire to increase the extended role of the pharmacist in respect of the services that they offer, not just in the community, which is stated in the guidance note, but also in their premises. That means face-to-face contact; giving authoritative, credible advice to patients who visit those highly accessible premises.
We have probably all visited pharmacists in our constituencies who are expanding their role—they measure blood pressure, do tests for diabetes and a range of other things—and pushing the boat out in terms of the responsibility that they are prepared to accept, the sort of advice they give to people and the autonomy with which they practise. For that to work, there must be an accessible pharmacist in the practice. If they are not accessible, they are nothing at all.
In recasting their image of pharmacists, people are looking for someone who is there, and accessible. The advantage that pharmacists have over GPs is that they are in the high street and behind fewer barriers than is traditionally the case with general medical practitioners. I hope that such thinking lies behind the Minister’s intention that there should be a limit on the number of practices that pharmacists are able to supervise. If that is not the case, I am inclined to agree with the hon. Member for Northavon that all that would be needed was some superintendent pharmacist, remotely located, sitting behind a computer screen and fielding calls from the periphery put in by people with a basic level of training perhaps not that much greater than that of anybody who is engaged in selling a product. If that is the case, the safety case for restricting the number of premises pharmacists can supervise has not yet been made to my satisfaction. I know that it has been cited by representative bodies of the pharmaceutical profession, and they may be right. However, to date, I have been less than convinced that they are.
I am wholly signed up to the idea that if the role of pharmacists is to be extended and people are to have confidence in pharmacists in their new role, which is what we all want to see, then it has to be conducted one to one and face to face rather than one conducted at arm’s length from some remotely located office.

Steve Webb: I follow with interest what the hon. Gentleman is saying and have some sympathy with it. However, would it not be possible for that to happen now with no legislative change at all? Presumably, we could just say to pharmacists that we want them to be more face to face, out at the counter chatting to people and not behind the scenes. This is about spreading pharmacists more thinly, which is perhaps the opposite of what the hon. Gentleman wants to see.

Andrew Murrison: The hon. Gentleman makes a good point. We have to face the difficulty with making pharmacists more accessible. By putting them out in to the community, and sending them into general practitioner’s surgeries to do smoking cessation clinics and the rest of it, we are spreading them very thinly. That, of course, creates a problem. When someone goes to collect their prescription or for some health care advice, as they have been encouraged to expect to be able to do in their high-street chemist, they will find that the pharmacist is not there and they are faced by a very nice but relatively unskilled person who is simply retailing items. Next time, they will not have the same level of confidence in their high-street chemist.
The Minister will have to decide to what extent she will push pharmacists out into the community to do outreach and to what extent she will have them in the high street, where they are a reliable point of contact for people who seek health care advice. We are expecting pharmacists to spread themselves relatively thinly, so we cannot necessarily reconcile those two things. That is absolutely correct.
I hope that the Minister will be able to reassure us that she is not stretching pharmacists too thinly and that she will pursue the model of high-street pharmacy that she and her colleagues have been encouraging these past few years. I hope that she will focus heavily on the idea that people should have confidence that in their high street there will be a reliable, regular pharmacist with whom they will be able to have face-to-face contact and to discuss the increasing range of health care conditions that I believe the Minister intends should be the province of pharmacy.

Jane Kennedy: Clause 24 deals only with the supervision of the sale and supply of prescriptions and pharmacy medicines, including remote supervision, not the personal control of a pharmacy by a pharmacist. We will be dealing with that in later clauses. There are variations in the interpretation of the pharmacist supervision requirements in section 10 and section 52 of the Medicines Act 1968. For example, the degree to which the pharmacist must personally supervise the preparation, assembly, sale and supply of medicines from the pharmacy, and the degree to which he must be involved in those activities, is unclear. Consequently, that often has to be determined by the courts. The aim is simply to remove the confusion about precisely what level of involvement a pharmacist must have in an individual transaction to be properly regarded to have supervised it personally.
We are not pushing pharmacists out into the community in the way that the hon. Member for Westbury (Dr. Murrison) suggests. Pharmacists—particularly those working in a communal pharmacy—are constrained from making better use of non-pharmacist staff by the supervision requirements in the Medicines Act 1968. Those provisions tie the pharmacist to the dispensing bench. They are restricted from making wider use of their clinical training to offer other services from the pharmacy, such as advice on the effective use of medicines.
I am sure that all parties would want pharmacies and pharmacists to be better able to use non-pharmacist staff, and to improve the use of their different skills and experience. We are introducing new arrangements that allow the pharmacist to delegate certain preparation-dispensing and supply activities to non-pharmacist staff. For example, the pharmacist may clinically check the prescription, and then instruct a suitably trained dispensing assistant to select the appropriate pre-packaged medicine from the pharmacy shelves, to cross-check that with another member of pharmacy staff, and to hand it over to the patient, without the further direct involvement of the pharmacist. Let me offer another example: a dispensing assistant may select the medicine from the shelves and make it ready for handing to the patient after the pharmacist has checked it.
Where suitably trained staff support the pharmacist, both of those practices are acceptable and can be done perfectly safely. The clause allows us to make the law clear on that point through regulations. We would have to legislate to make that change; we would need to do that. I sometimes look to find ways in which we can ease the regulatory burden while retaining and reinforcing safe practices, and this is a straightforward and sensible way to do that. The pharmacist does not need to supervise personally at all times suitably qualified and trained staff, such as pharmacy technicians, who are working to written procedures for safe working set down by the pharmacist in charge of the pharmacy.
At the same time as exercising this new power, we intend to use existing powers in the Medicines Act 1968 to enable suitably trained and registered pharmacy technicians, or other suitably trained health professionals, to supervise the dispensing or sale of medicines, except for certain activities that must be undertaken by the pharmacist. There will always be things that the pharmacist does that they will be required to do.

Steve Webb: The Minister says that there will always be some things that only the qualified pharmacist can do. Can she give the Committee a flavour of what she means by that? What can be legitimately delegated to the technicians, and what can the pharmacists alone do, and what does that imply for the physical presence of the pharmacist?

Jane Kennedy: I am cudgelling my brain, but at this moment I cannot think of an example. However, I will get examples, and I will write to the hon. Gentleman to  explain them, so that he has a picture of exactly what we envisage taking place. At present, however, I cannot offer such an example without inspiration.
Without the amendments and the clause, the pharmacist would be tied in a way that would not enable us to achieve the development of their role and fully exploit their skills.

Question put and agreed to.
Clause 24, as amended, ordered to stand part of the Bill.

Clause 25 - Control of pharmacy premises: individuals and partnerships

Steve Webb: I beg to move amendment No. 123, in clause 25, page 22, line 2, at end insert
‘but nothing in this section shall be taken to require a pharmacist to be present on those premises when medicinal products on a general sale list are sold by retail.’.
This is a probing amendment; we seek clarification. Clause 25 deals with individuals and partnerships. I have questions about the implications of the clause in respect of the particular case of what are called general sale list products—products that do not need a pharmacist to be present to be sold, such as the kind of product that someone might buy in a garage shop. We simply want to be clear that clause 25 would have no impact on general sale list products or on the requirement for pharmacists to be present. If the Minister can reassure us that that is implicit or, indeed, explicit in the clause, we would be more than happy.

Jane Kennedy: I appreciate the way in which the hon. Gentleman moved the amendment. The Medicines Act 1968 does not require a pharmacist to supervise the sale of general sale list medicines. The public can buy those medicines in several retail outlets, such as newsagents, garage shops and supermarkets—we all know them—without the need for a pharmacist to be present on the premises. However, the lack of clarity about the personal control requirements in the Act has led to the common interpretation that pharmacists exercise control over the pharmacy business only when they are physically present in the pharmacy. That has led to the view that the exercise of personal control over the pharmacy requires the pharmacist to be present when general sale list medicines are sold. Thus, an anomaly has been created. Someone may buy a general sale list medicine from a local corner shop, but if he visits a pharmacy, and the pharmacist is not present, he must go elsewhere to make the purchase. That is nonsense.
The Bill replaces the personal control requirement with a requirement that each pharmacy should have a responsible pharmacist in charge of the pharmacy business in so far as it relates to all medicines, including those on the general sale list. The responsible pharmacist will not be required to be on the premises at all times, and it will be for the pharmacist to decide whether the pharmacy will sell general sale list  medicines when he or she is not physically present. We assume that most responsible pharmacists will decide that their pharmacies can do so.
As a result of the changes in the Bill, the present anomaly will disappear, so the hon. Gentleman’s amendment is not necessary. I hope that that addresses his concerns in tabling the amendment. The Bill places pharmacies on a more equal footing with other outlets selling general sale list medicines.

Steve Webb: In a sense, our amendment related to the opposite group of premises—those where general sale list medicines are on sale and there is currently no requirement for supervision. We merely sought to clarify that clause 25 would not introduce a new requirement, and the Minister has broadly satisfied me that that is indeed the case. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.
Question proposed, That the clause stand part of the Bill.

Steve Webb: In her response on clause 24, the Minister indicated that some of our remarks might have been more appropriately directed at clause 25, and I apologise if that was the case. However, I just want to gnaw away further on the issue of supervision.
Would it be accurate to say that we are dealing in clause 25 with a calculated risk? I do not say that pejoratively; I simply think that that, objectively, is what we are doing. For the past 37 years, we have said that a pharmacist must be present, and if they nipped out to the loo or went over the road, the pharmacy could not sell medicines. We are now saying that we want pharmacists to do other things, so we will allow pharmacies to make available medicines that they have not been allowed to make available for the past 37 years without a pharmacist being present. We are trying to minimise the risk arising from that relaxation of the rules by setting out in regulations who can sell medicines and in what circumstances.
My question is whether the Government have done any risk assessment on clause 25. There must be a risk associated with selling medicines without a pharmacist being present, when they would hitherto never have been sold with a pharmacist present. There must be a risk associated with the pharmacist being on the other end of a webcam or a phone and not being physically present. How big a risk is that? Has the nature of that risk been assessed? How far will the regulations limit that risk?
Do the Government envisage that in the vast majority of cases a pharmacist will still be physically present? That is an important question for us on these Benches. Is the regime that is envisaged one in which pharmacists will have a bit of spare time in which they can be away from the premises if they have to do something worth while, but that that will be exceptional—the norm will still be that the main pharmacist attached to one set of premises will be there? Alternatively, are we envisaging a world in  which, because we are convinced that the change is very low risk and there are enough trained people out there to cover for them, pharmacists will play a light-touch supervisory role? Are we changing from hands-on, got-to-be-on-the-premises people, without whom nothing can be sold, to a regime of light-touch oversight of several premises? How far down that route do the Government expect clause 25 to take us?

Jane Kennedy: I agree with what I think is the hon. Gentleman’s main concern. The public place importance on being able to see and obtain advice from the pharmacist. It is important for people to be able to identify the responsible pharmacist in a pharmacy, and that is where clarification is needed. The law does not specifically say that a pharmacist has to be present, but that is how it has been interpreted. We expect that the responsible pharmacist will spend the majority of his or her time in the pharmacy. The way the time of pharmacists is used is down to the contracts between them and the primary care trusts that commission their services.
Because we want the public to have the reassurance of knowing who the responsible pharmacist is in a pharmacy, we have taken the step of changing the requirement in section 70 of the 1968 Act for the pharmacist in personal control of the pharmacy to exhibit conspicuously in the pharmacy his or her registration certificate.
In practice, most, if not all, pharmacists working in pharmacies display their certificates, so there is an expectation that they will always be there. Now, we are going to say that the responsible pharmacist will be required to display conspicuously in the pharmacy a notice stating that he is the pharmacist in charge of the pharmacy on that day and at that time, and giving his registration number. That will help the public to identify the pharmacist in charge, particularly in cases in which more than one pharmacist is present in a pharmacy. It will also allow the public to know when the pharmacist in control is not physically present.
Subsection (5) replicates the current provision that somebody who has been registered as a pharmacist in Great Britain for less than three years may not be in charge of a pharmacy. I hope that I have answered the hon. Gentleman’s concerns. The way in which the law has developed in this area is a little strange, and I think that what we are doing will be welcomed. I know that there are concerns that our intention is to dilute the role of the pharmacist. That is not the case. Indeed, we are working closely with the Royal Pharmaceutical Society to ensure that we maintain the strong support that we have among pharmacists for the developments in this legislation.
 I have inherited a piece of work that has been under way for many years, and this change is a sensible step. In taking it, we can be confident that we are retaining the regulations necessary to allow for patient safety to be properly maintained.

Question put and agreed to.
Clause 25 ordered to stand part of the Bill.

Clause 26 - Control of pharmacy premises: bodies corporate

Question proposed, That the clause stand part of the Bill.

Andrew Murrison: Clause 26 gives us the opportunity to have another bite of the cherry. It deals also with the issue of supervision—writ large, I suppose, because we are dealing with bodies corporate. We might understand that to mean, for example, some of the larger chains of pharmacies.
My concerns and those of the hon. Member for Northavon (Steve Webb) have not been entirely explored by the Minister; perhaps she will think about the issue further in our debate on this clause. There seem to be two aspects to the argument about supervision. One concerns safety and one concerns the quality of the extended role of the pharmacist. We can all understand that it is important for someone to be on hand to check prescriptions and make sure that there are no drug interactions or other technical matters such as name conflicts. As the Minister has hinted, many of those tasks can be dealt with through remote and electronic means, such as telemedicine, which embrace new technology.
If we took that to its logical conclusion, as the hon. Member for Northavon pointed out, we could produce a system in which a superintendent pharmacist employed by Boots the Chemist sat in an office in London and fielded calls from the hundreds of pharmacies scattered around the country. The quality of the advice given would probably be very good and it would clearly be auditable in a way that it currently is not. That model therefore has some advantages. It is for the Minister to say why a limit needs to be set on the number of pharmacies that a pharmacist might be able to supervise, if the argument is to do with patient safety. I think that the Minister may struggle to explain that, but I should be interested to hear her thoughts.
There is another strand to the question, however, which concerns the developing role of the pharmacist. It relates to large pharmacies in the same way as small single pharmacist-owned premises of a traditional sort, in a high street. The argument for limiting the number of pharmacies that can be supervised in those circumstances is far clearer. If we are to develop the role of the pharmacist in that way, which would be a good thing, it makes sense to ensure that individuals who turn up at high-street chemists can have confidence that they will deal with a qualified pharmacist, because of the issues of accessibility and immediacy that lie at the heart of the developing role of the pharmacist.
The more I think about the two aspects of the matter, the more I am convinced by the questions of the quality of the extended role of the pharmacist, and the less I am convinced by questions of safety. The whole matter comes to a head when we consider bodies corporate and how larger chains of pharmacies might manage with one superintendent pharmacist sitting in an office dispensing advice. He or she would certainly  tick the box for safety—at least I have not seen any convincing evidence to the contrary—but manifestly not the box for face-to-face patient contact.
With those issues in mind, I must press the Minister on why and how she will insist on a particular number of pharmacies that a pharmacist may supervise. I suspect that the number will be low—in fact, from what we understand comes later in the Bill, I suspect that it is one. If so, I should be grateful to know the rationale for that. One can easily demolish the safety rationale but not—quite the reverse—the rationale based on the extended role of the pharmacist. What is driving the Minister’s thinking in limiting the number of pharmacies that pharmacists may supervise?

Jane Kennedy: The limitation on the number of pharmacies that a pharmacist can supervise and be responsible for is something that we shall come to on clause 28, but it might help the Committee if we deal quickly with it now. The clause sets the general rule that a pharmacist will generally be in charge only of one pharmacy. Clause 26 replaces the requirement under section 71 of the Medicines Act 1968 that requires each pharmacy carried on by a body corporate to be under the personal control of the pharmacist with a requirement for each pharmacy to have a responsible pharmacist. Those requirements are essentially the same as those in clause 25, which relates to small pharmacies owned by individuals and partnerships, except for subsection (1)(a) of the new section 71 that deals with the superintendent pharmacist, which is really what the clause is about.
A body corporate conducting a pharmacy business must appoint a superintendent pharmacist, the rule of whom is company wide. The superintendent pharmacist is there to ensure that the body corporate meets the statutory requirements relating to pharmacy premises. He has an important standard-setting role for the conduct of the pharmacy business, including how it reflects standards set by the professional regulatory bodies. The clause ensures that the role of the superintendent pharmacist will continue, as now, under the Medicines Act. The responsible pharmacist, under clause 28, will continue to be under the direction of the superintendent pharmacist.
We sought views on the role of the superintendent pharmacist, as the pharmacist in control of each pharmacy is subject to the general direction of the superintendent pharmacist. The response to public consultation was that more detailed debate was needed on the role of the superintendent pharmacist before considering changes so, for now, we are concentrating on the responsible pharmacist as the key change that will end the uncertainties that we have just debated about personal control requirements.
We shall continue to discuss with the profession how we can develop further the role and where further regulatory reform needs to take place. As now, the responsible pharmacist will continue to be under the  direction of the superintendent pharmacist and, other than the changes that we have discussed, there will be little further change to the role.

Question put and agreed to.

Clause 26 ordered to stand part of the Bill.

Clause 27 ordered to stand part of the Bill.

Clause 28 - The responsible pharmacist

Andrew Murrison: I beg to move amendment No. 17, in clause 28, page 24, line 24, leave out from ‘time’ to end of line 25.

Eric Illsley: With this it will be convenient to discuss the following: Government amendment No. 92.
Amendment No. 19, in clause 28, page 24, line 41, after ‘pharmacist’, insert ‘having regard to—
(a)the establishment of clear lines of accountability within the pharmacy;
(b)provision for the responsible pharmacist to be contactable when absent;
(c)the maximum time for the responsible pharmacist to return to the pharmacy; and
(d)provision for the responsible pharmacist to justify any absence.’.

Andrew Murrison: I will deal with amendments Nos. 17 and 19. The first amendment would delete in relation to the provision that
 “A person may not be the responsible pharmacist in respect of more than one set of premises at the same time”,
the words
“except in circumstances specified by the Health Ministers in regulations.”
We want to make it clear that a pharmacist may be responsible for just one pharmacy at any one time and the amendment would remove the expectation that Ministers may be able to alter that.
If the Minister is not minded to accept the amendment, I hope that she will at least give the Committee an idea of the circumstances she envisages in which it would be acceptable for a pharmacist to supervise more than one pharmacy. In a sense, I suppose that she has covered some of that ground already, but now is an opportunity to explore further the rationale behind the limitation of the number of premises that a pharmacist can supervise.
The Minister has been good and has answered the worries of hon. Members. Nevertheless she has not really dealt with the central issue of whether we are being driven by a safety case or by a need to protect and enhance the extended role of the pharmacist. As I have said about previous clauses, it is increasingly my view that the safety case can be made for remote supervision. Perhaps we are not at that stage at the moment. We would have to explore the matter further, but we are going in that direction.
The case for the extended role of the pharmacist is far less clear and that is why I am suggesting in a probing way that we delete the words whereby pharmacists can supervise more than one set of premises at Ministers’ discretion. That is the intention of amendment No. 17.
 Amendment No. 19 is a little more complicated because it would establish parameters under which pharmacists may operate. As part of the amendment, we have laid out a number of parameters that Ministers would have to consider in drafting regulations in relation to the responsible pharmacist. Those parameters concern the establishment of clear lines of accountability within pharmacies, the provision for the responsible pharmacist to be contactable when absent, the maximum time for the responsible pharmacist to return to the pharmacy, and provision for the responsible pharmacist to justify any absences. In other words, we are saying that the pharmacist will normally be at the pharmacy.
We are saying that it is not really acceptable for pharmacists to regard their pharmacy as a base camp from which they operate an itinerant practice, so that they cannot reliably be found at the pharmacy at any one time. That approach seems to cut across the developing role of the pharmacist that we have seen in recent years, which we regard as a fairly positive thing. I would be concerned if it became the rule rather than the exception that pharmacists were absent from their premises and doing, other albeit worthwhile, things. I hope that the Minister will consider our amendments favourably.

Jane Kennedy: Amendment No. 92 is a minor technical amendment to the Medicines Act 1968. I appreciate the main concern that the hon. Gentleman has articulated. Under the 1968 Act, maintaining patient safety is paramount. We believe that the changes proposed and the conditions to be set in the regulations will maintain patient safety. I accept that there is anxiety about the opportunities that might arise to exploit any flexibility in the rule of “one responsible pharmacist, one pharmacy.” However, the intention is that regulations will be tightly drawn as to the specified circumstances and conditions that must be met to allow exceptions to that general rule. Those regulations will be subject to further discussion and consultation with all interested parties.
I think that, by and large, we agree that the general rule should be “one responsible pharmacist, one pharmacy”, but we also think it sensible to allow sufficient flexibility to consider and, if necessary, to respond to circumstances that may arise in which a responsible pharmacist might be permitted to be responsible for more than one pharmacy at any one time.
Let me give the Committee a couple of examples. There may be changes in the way in which pharmacy services are provided, such as a case in which the responsible pharmacist controls the supply of certain medicines in another location. For example, a pharmacy service might be provided to offer sale of over-the-counter medicines to meet the needs of a large number of people attending an event that extended  over several days. The service might be delivered by trained staff, such as pharmacy technicians, with the pharmacist responsible for a pharmacy in a nearby village or town also becoming responsible for the safe running of that additional pharmacy.
Amendment No. 17 would restrict a responsible pharmacist to one pharmacy only in exercising his duty and, as I have just described, there are circumstances in which I believe that that greater flexibility should be allowed. Amendment No. 19 would restrict the responsible pharmacist as to when and how he might be absent from the pharmacy. The proposed changes are unnecessary, as there is already provision in relation to that in the Bill. We would expect the pharmacy for which the pharmacist is responsible to be the responsible pharmacist’s main place of work. We would also expect them to remain contactable so that they can provide advice or arrange for another pharmacist to do so. These provisions and other provisions on, for example, written procedures will ensure the safe and effective running of the pharmacy, including when the responsible pharmacist is away from the pharmacy. As I said, we expect the responsible pharmacist to be on the premises, by and large, but the provision allows for consideration of developing services, which is a sensible route to follow.
The new provisions will help to remove restrictions on the pharmacist’s ability to provide a range of other services, including working with other health professionals such as GPs. We intend the regulations to set out the conditions that must be met to permit an exception to the rule of “one responsible pharmacist, one pharmacy”. The House will have the opportunity to debate those regulations later.
As I said, amendment No. 92 is a minor drafting amendment that tightens the regulation-making power to provide not only that responsible pharmacists may be responsible for more than one pharmacy, but that the regulations may require the responsible pharmacist to comply with certain conditions. Such regulations need to be tightly drawn. We intend to consult representative bodies on the circumstances in which it may be appropriate to consider an exception to the “one responsible pharmacist, one pharmacy rule”. I therefore hope that the Committee will accept amendment No. 92. I also hope that I have reassured the hon. Member for Westbury, and that he will withdraw his amendment.

Andrew Murrison: The Minister has undertaken to ensure that regulations are—in her words—tightly drawn. I therefore beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendment made: No. 92, in clause 28, page 24, line 25, at end insert
‘, and then only if such conditions as may be so specified are complied with.’.—[Jane Kennedy.]

Andrew Murrison: I beg to move amendment No. 18, in clause 28, page 24, line 40, after ‘Ministers’, insert
‘, having consulted with representative bodies,’.

Eric Illsley: With this it will be convenient to discuss amendment No. 122, in clause 28, page 25, line 29, at end insert—
‘(12)Before making regulations under this section the Health Ministers shall consult such persons as appear to them to represent persons providing pharmaceutical services.’.

Andrew Murrison: Amendment No. 18 is a simple amendment that follows on from several rather similar amendments that we have tabled to the Bill. It would insert into the Bill the need to consult representative bodies before Health Ministers make further provisions relating to the responsible pharmacist. It is driven by the profession’s desire to influence what happens, and by a feeling that it is appropriate for Ministers to consult pharmacists closely before they make any regulations under the Bill. That is entirely reasonable.
The Minister said in relation to the previous group of amendments that she intended to consult representative bodies, which is a good thing. Nevertheless, it is appropriate to insert such a duty into the Bill, because consulting representative bodies is important. I very much hope that she will consider the amendment favourably.

Stephen Williams: The hon. Gentleman was uncharacteristically brief, so I rise briefly to speak to amendment No. 122, which seeks to achieve a similar object. We discussed consultation in our consideration of part 1, in which the Minister with responsibility for public health resisted the suggestion that the Royal Institute of Public Health should be consulted. I hope that the Minister present will have an entirely different attitude. If the legislation is to work, it is important that all the bodies with a professional interest are consulted, and I hope that, just for once, the Government will be open minded and accept an Opposition amendment.

Jane Kennedy: I am always open minded—well, mostly. I shall consider the hon. Gentleman’s point and, if necessary, I will write to him. However, both amendments are unnecessary. The Bill inserts new sections into the Medicines Act 1968. Section 129(6) of that Act already imposes a statutory requirement for there to be consultation of representative interests before making regulations. By virtue of that section, we already have a statutory obligation to consult interested parties before making regulations under the new powers inserted into the Act by this Bill. I therefore recommend that the Committee rejects the amendments. I appreciate the tone in which the hon. Member for Westbury moved amendment No. 118, but I hope that he does not press it to a vote, because that would be a shame at this late stage, in an afternoon just before Christmas.

Andrew Murrison: I detect a note of desperation. For that reason alone, I am tempted to press the amendment to a vote, but as it is Christmas, I shall not. The Minister has given us plenty of reassurances and the point about consulting representative bodies is on  the record. That is good. With that in mind, and in the spirit of Christmas, I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Amendments made: No. 93, in clause 28, page 25, line 16, leave out ‘under’ and insert ‘made by virtue of’.
No. 94, in clause 28, page 25, line 22, leave out ‘under’ and insert ‘made by virtue of’.
No. 95, in clause 28, page 25, leave out line 37 and insert
‘making of entries in a record relating to the responsible pharmacist),’.
No. 96, in clause 28, page 25, line 39, leave out from ‘of’ to end of line 40 and insert ‘the record).” ’.—[Jane Kennedy.]

Clause 28, as amended, ordered to stand part of the Bill.

Clauses 29 and 30 ordered to stand part of the Bill.

Clause 31 - Power to charge

Steve Webb: I beg to move amendment No. 121, in clause 31, page 26, leave out lines 20 to 40 and insert
‘(1)The Secretary of State may give directions to a Primary Care Trust requiring it to charge a fee to persons who make an application referred to in section 42(2)(c)(i) or (ii) to the Primary Care Trust.
(2)The Secretary of State shall in the directions specify the fee to be charged, which may vary according to the type of application being made but not according to the place in England where it is made.
(3)Before determining the amount of any fee to be charged the Secretary of State must consult such organisations as he thinks fit that appear to him to represent persons providing pharmaceutical services and such organisations as he thinks fit that appear to him to represent Primary Care Trusts.
(4)The Secretary of State must publish in such manner as he thinks fit any directions he gives under this section.’.

Eric Illsley: With this it will be convenient to discuss amendment No. 21, in clause 31, page 26, line 28, at end insert
‘(c)require Primary Care Trusts to refund the fee if an application is not determined within 28 days.’.

Steve Webb: We are powering ahead, which is great, and we come now to part 4, which deals with pharmaceutical services. The clause relates to the power for charges to be levied in respect of a chemist’s application to a pharmaceutical list. I hope that at some point we discuss the broader issues of entry and control of entry in respect of pharmaceutical supply. A number of us are concerned about the position of community pharmacies and the small local pharmacist as distinct from a pharmacist in a supermarket or something similar. I hope that we will discuss some of those issues in due course, but amendment No. 121 is much more specific. It would replace lines 20 to 40 on page 26 of the Bill, which contain provisions on the power to charge relating to England. The amendment is essentially a reformulation of those provisions.
Subsection (2) of the amendment would ensure that when the Secretary of State determines what fee can be charged, variation of the charge for any given type of application in different parts of England will be precluded, although there could be variation according to the nature of the application. This is an England-only clause, and we are trying to get consistency in the charges that might be levied, rather than allow charges that might vary according to primary care trust.
Beyond that, many of the reformulations in our amendment are similar to the original clause. For example, subsection (3) of the amendment is about consultation, and consultation provisions are in the original clause. The amendment would not much change the spirit of what is already in the Bill, but it would avoid some unnecessary variation in fees across the country. We think that it would tidy things up a bit, although that might be going a bit far. That is the spirit behind the amendment.

Andrew Murrison: I think we are grinding to a conclusion, although not before we consider a couple of helpful amendments, the second of which is our amendment No. 21. It is quite simple and has to do with our concern that the determinations should be made in a timely fashion.
I am afraid that businesses constantly tell us that they are frustrated by bureaucracy failing to deliver within a reasonable time frame. Amendment No. 21 would insert words that allow the fee to be refunded if the matter is not determined within 28 days. That seems entirely reasonable to us, and I hope that the Minister, in a spirit of trying to ensure that business is dealt a fair hand, will consider it carefully.
Very few commercial organisations would consider our amendment unreasonable. Given that we are dealing with the interface between the NHS and commercial organisations, both working together to provide a service to patients, it seems appropriate to ensure that any requirements of the regulations are discharged within a reasonable time. Twenty eight days seems reasonable to us and would give an incentive for things to be determined speedily and in a timely fashion.

Jane Kennedy: Clause 31 introduces a power to charge fees, as has been described. Primary care trusts will be required to levy such charges, which applicants will have to pay. We envisage that the Secretary of State, rather than primary care trusts, will determine the level of fee to ensure consistency. Fees would be determined only after consultation with appropriate bodies. However, a facility for primary care trusts to set the charges may be desirable in future, in line with our general policy of devolving decision making to the local level as far as possible. Subsections (2)(b) and (3)(b) of proposed new section 42A will require primary care trusts to determine and undertake local consultations on such fees in accordance with national requirements set out in the directions. That is the background.
The amendments pose an interesting set of challenges. I cannot support amendment No. 121, and shall explain why. First, Although the hon. Member for Northavon said that it would apply only in England, it would introduce different charging regimes in England and Wales. That is not what the measures intend.
Secondly, the amendment would prevent differential fee levels from being set for different types of application between different primary care trusts. In other words, there would be only one fee level for a particular type of application, and that would be determined nationally. That determination would only ever be for the Secretary of State to make, but we do not envisage that the Secretary of State is likely to want to determine fees differentially, according to which primary care trust decides an application. However, should the Secretary of State decide that that power is needed, the amendment would prevent that from occurring.
Thirdly, the amendment would mean that the Secretary of State could not, at any time he or she might choose, devolve the decision about fees to primary care trusts. As I made clear, such devolution of powers would be subject to whatever national requirements the Secretary of State chose to set out in directions, including in relation to whatever consultations the PCT must first undertake locally.
The amendment would make the determination of fees always the responsibility of the Secretary of State and would mean that they could never be devolved to PCTs. That does not sit well with the Prime Minister’s principle for public sector reform, which makes it clear that there is a need to devolve decision making to the lowest level wherever appropriate. We had some fun at the expense of the hon. Member for Northavon about the centralising nature of Liberal Democrat policy, but in the spirit of bonhomie I resist the temptation to go down that route.
I assure the Committee that we do not envisage directing PCTs simply to set whatever fees they think appropriate, but the Secretary of State might want to set out in directions a maximum fee that PCTs may charge for each type of application and leave it to them to consult on the fee levels that they wish to set up to that maximum level. The amendment would prevent that. I reassure the Committee that we have no intention of allowing PCTs to set extortionate or excessive fee levels. We would always ensure that they were reasonable, proportionate and fair in relation to the work involved for the NHS. For those reasons, I cannot support or accept the amendment.
Amendment No. 21—it is confusing to have amendments Nos. 121 and 21; I keep having to remind myself which one I am referring to—would give the Secretary of State powers to require PCTs to do as the amendment describes. There is undoubtedly a need for pharmacy applications to be dealt with as quickly as possible. That concern was acknowledged in the reforms of pharmaceutical services that we made earlier this year. The NHS (Pharmaceutical Services) Regulations 2005 introduced new time limits for the determination of applications.
With applications for inclusion in PCT pharmaceutical lists, the regulations require PCTs to reach decisions
“as soon as is practicable, and in any event within ... four months ... of receipt”
unless there is “good cause” to extend that time limit. There are several stages to go through before a PCT can reach a decision, one of which involves notifying interested parties about the application and giving them 45 days in which to comment. Interested parties include the local pharmaceutical and medical committees, persons on the PCT’s pharmaceutical list who are likely to be significantly affected and the patient’s forum for the PCT area. We do not want to reduce that consultation period, because the organisations concerned need time to respond meaningfully. I know from comments made by the hon. Member for Westbury in previous discussions how important he views consultation to be. Therefore, we would never want to exercise a power such as that proposed in the amendment, as it would mean PCTs refunding fees charged on new applications every time.
Other types of application are more straightforward, such as one from a chemist who wishes to move a short distance or ones involving a change of ownership. Those are dealt with administratively by PCTs, and the regulations require them to reach a decision within 30 days either to grant the application or to determine that the normal procedure should apply. Therefore, the PCTs must still check the details; they must still prepare reports and reach their decision. Although many such applications will be clear cut, we will have to build in contingencies to allow for circumstances in which a PCT quite reasonably and through no fault of its own takes longer than 28 days to decide. For example: a PCT might have to clarify details with the applicant; an application might contain factual inaccuracies; or a PCT might have to carry out other checks on the applicant, such as into their fitness to provide NHS services.
It would be difficult to capture in directions the potential range of circumstances that might reasonably apply in such cases, and it would be unreasonable to require a PCT to make a refund if it has simply followed the correct legal procedures and processes. The current regulations make sufficient provision for applications to be dealt with efficiently and effectively. PCTs do not need any greater incentives to act speedily under the regulations.
I appreciate the reason behind the amendment, but I ask the hon. Member for Northavon to withdraw it, given my explanation of Government policy.

Steve Webb: As a committed decentraliser, I am chastened by the Minister’s response and urgently beg the Committee’s leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 31 ordered to stand part of the Bill.

Clause 32 - Applications for provision of pharmaceutical services

Question proposed, That the clause stand part of the Bill.

Steve Webb: I have a couple of questions for the Minister. In line 42 there is a reference to two or more applications to provide pharmaceutical services in the same neighbourhood. Would the Minister clarify what is meant by “neighbourhood” in that context? Is it a town, a county or a PCT area? What is the scope of the clause?
I hinted at my other question during my earlier intervention. All of us would want the character of community pharmacies to be maintained. Individual pharmacies have a role, as do big chains, and where applications are made by two pharmacies, or where an application is made by a new one in the same neighbourhood as an existing one, what criteria would the Government use for determining which should be allowed to operate? Do they just wish to encourage entry and competition?
 I am worried that if it is a matter of full-blooded, full-throated competition, there is a danger that community pharmacies and the services they provide, which bring something distinctive to our neighbourhoods, might be driven out of business by the chains. They can cross-subsidise, and drive out smaller pharmacies that are not able to do that, to the long-term detriment of variety, quality and customer service. Would the Minister put on record the criteria that the Department require to be used locally in deciding between competing applications in a neighbourhood? It would be helpful if she could do that and clarify what constitutes a neighbourhood.

Jane Kennedy: One of the beauties of devolving decision making to a local level is that it allows me to stand up in Committee and say that it is for the PCT to decide what the definition of “neighbourhood” is when it is inviting applications for a particular service. That will be determined by local circumstances. On the hon. Gentleman’s other point about the criteria, to make sure I get it right I will undertake to write to him, if he will allow me. I shall circulate the letter to Committee members so that everyone can see the criteria that we intend to apply.

Andrew Murrison: The hon. Member for Northavon makes a fair point. There does seem to be the potential for a lawyers’ beanfeast on the definition of “neighbourhood”. In determining the matter, PCTs may decide that two pharmacies are both in a neighbourhood, but one pharmacy might say, “We are in the next town, albeit one that is very close”. There is scope to be a little clearer about what is meant by “neighbourhood”. It might be simply defined as being in one PCT area. “Neighbourhood,” although it sounds very cosy, does not seem to be sufficiently clear to avoid giving lawyers a meal ticket.

Jane Kennedy: It has been my regular experience that in devolving decision making to the locality, very reasonable points are raised, like the ones raised by the hon. Gentleman and the hon. Member for Northavon, and I shall consider them. What constitutes a neighbourhood will be greatly influenced by local factors, but in my letter I shall flesh out our thinking on how we expect PCTs to work in relation to the definition of “neighbourhood”, if that is of assistance to the Committee.

Question put and agreed to.
Clause 32 ordered to stand part of the Bill.

Clause 33 - Arrangements for dispensing of medicines

Amendment proposed: No. 82, in clause 33, page 28, line 26, at end insert—
‘(2)In section 17S of the National Health Service (Scotland) Act 1978 (c.29) (eligibility to be contractor under pharmaceutical care services contract), after subsection (1) insert—
“(1A)In such circumstances, and subject to such conditions, as may be prescribed, subsection (1) has effect with the omission of the words from “who undertakes” to the end.”.’.—[Jane Kennedy.]

Andrew Murrison: I have to say that we were expecting a little more explanation. It is customary when tabling an amendment for some explanation to be given. Opposition Members, who have tabled many amendments during the past several days, have been exhaustive in their explanation of them. For the Minister simply to move the amendment formally does not cut the mustard. I would be grateful if she could explain the intention of the amendment.

Jane Kennedy: There is a saying in Liverpool: God loves a trier. That was an example.
The subject matter of the Medicines Act 1968 is reserved, but NHS legislation is devolved. Amendment No. 82 comes forward with the agreement of Scottish Ministers who were unable to conclude discussions when the Bill was introduced.
This amendment to section 17S of the National Health Service (Scotland) Act 1978 will bring NHS legislation in Scotland into line with the proposed changes to the 1968 Act, which are implemented by part 2 of the Bill. In the same way, clause 33 relates to NHS legislation covering England and Wales.
I hope that that explanation of the purpose of the amendment satisfies the Committee.

Amendment agreed to.

Gillian Merron: I beg to move, Mr. Illsley, that you, the Clerks and the Committee have a very happy Christmas and new year.
Further consideration adjourned.—[Gillian Merron.]

Adjourned accordingly at twenty-one minutes past Four o’clock till Tuesday 10 January at twenty-five minutes to Eleven o’clock.